CEPA: LESSONS FOR CHEMICAL REGULATION Joseph F. Castrilli, Counsel Canadian Environmental Law Assoc. Webinar: Science Meets Law December 12, 2019
Overview What is CELA? Nature of the Problem Posed by Toxic Substances in Canada CEPA Existing Chemicals New Substances Looking Forward 2
What is CELA? • Non-profit organization established in 1970 to use existing laws to protect the environment and to advocate environmental law reforms • Funded by Legal Aid Ontario - Provides free legal advice to the public & legal representation at hearings and in courts on behalf of those otherwise unable to afford legal assistance • Also undertakes education & research projects 3
Nature of the Problem • Approx. 23,000 chemicals in use in Canada DSL • Approx. 58,000 chemicals on NDSL • Some cause cancer, birth defects, endocrine disruption, neurological & behavioural impacts … • Ontario: #2 in North America for release of developmental/reproductive toxicants (CEC 2004) • Ontario: #4 in North America for release of known/suspected carcinogens (CEC 2004) • Ontario: responsible for 36% of air / 50% of water discharges in Canada (Ontario 2008 Discussion Paper on Toxics Reduction Law) 4
Timeline History of CEPA • Canada has had toxic substance legislation in one form or another since the mid-1970s • Environmental Contaminants Act (1975 – 1988) • Canadian Environmental Protection Act (1988 – 1999) • CEPA,1999 (current law) 5
CEPA: Introduction • Canadian Environmental Protection Act,1999 – principal law governing manufacture, import, & use of chemicals in Canada • Primary purpose “to contribute to sustainable development through pollution prevention ” (CEPA,1999 – Declaration); also • “ Virtually eliminate most persistent & bioaccumulative toxic substances” (Preamble) • Federal government duties include: protection of environment & human health through application of precautionary principle (s. 2) 6
CEPA: What is toxic? • Under CEPA,1999 a substance must be declared “toxic” before Canada can act to reduce exposure • “toxic” defined as a substance entering or that may enter the environment in a quantity or concentration or under conditions that: 7
CEPA: What is toxic? • Have or may have immediate / long-term effect on environment or its biological diversity; • Constitute or may constitute danger to environment on which life depends; or • Constitute or may constitute danger in Canada to human life or health (s. 64) 8
CEPA: What is toxic? • If a substance meets s. 64 test it can be added to Schedule 1 of Act (List of Toxic Substances) & become eligible for regulation (following public notice, comment and Board of Review hearings) • For both existing and new chemicals CEPA,1999 applies risk assessment approach to determine whether s. 64 test met 9
CEPA: Existing Chemicals • If a substance is on the Domestic Substances List it is deemed an existing substance; & would be on that list if it was used, manufactured, imported for commercial purposes in volumes greater than 100 kg between January 1, 1984 & December 31, 1986 (s. 66, CEPA,1999) • Approximately 23,000 substances on DSL 10
CEPA: Existing Chemicals • Substances on DSL categorized as to persistence, bioaccumulative, toxic, & exposure potential to humans & environment within 7 years after CEPA,1999 became law (s. 73) • Substances not on DSL placed in non-DSL list & cannot be manufactured or imported unless information first provided to government of Canada (essentially deemed to be new substances) 11
CEPA: Existing Chemicals • Assessment of DSL substances to determine which should be deemed toxic & placed in Schedule 1 has been on-going under CEPA,1999 & predecessor law • To expedite review of existing substances categorization process authorized under s. 73 to identify chemicals that should be subjected to screening level risk assessment (s. 74) 12
CEPA: Existing Chemicals • Under categorization, chemicals were assessed on: – Environmental criteria (3): persistence (P); bioaccumulation (B) and; inherent toxicity (iTe) to aquatic organisms; & – Health criteria (2): greatest potential for exposure (GPE); and inherent toxicity to humans (iTh) – Canada completed categorization process by September 2006 13
What is Categorization? 14 Source: Environment Canada, Categorization of the Domestic Substances List For Persistence, Bioaccumulation, and Inherent Toxicity to Ecological Organisms, Technical Briefing to NGOs, April 20, 2006
Categorization Results • Categorization of 23,000 DSL chemicals resulted in Canada finding that 4,300 required further evaluation organized into 3 groups: • High priority – PBiTs, GPE/IPE and high hazard to humans • Medium priority – P/BiT, GPE/IPE and medium hazard • Low priority – P/BiT to aquatic environment, mainly low volume 15
Categorization Results - 4300 Substances Source: Government of Canada, Presentation to the CMP Stakeholder Advisory Council, January 30 2009, Ottawa 500 High Priorities 4300 Priorities 2600 Med 1200 Low Priorities Priorities 16
CEPA: Existing Chemicals - CMP • In December 2006, Canada announced new approach known as the Chemicals Management Plan, to address results of categorization by 2020 • Major focus of CMP: collect additional information on 4,300 substances out of 23,000 that require further assessment to determine if toxic to human health/environ. 17
CEPA: Existing Chemicals – Risk Management • CEPA-toxic chemicals go on Schedule 1 of Act & are eligible for risk management • Risk management options include: – Regulation (ban, restrict use or release, etc) – Pollution prevention (requiring minimization / avoidance of waste creation, etc) – Significant new activity (SNAC) (notification by industry beyond current uses) – Voluntary env. performance agreement 18
CEPA: Existing Chemicals – CMP Summary • CMP Focus: – Data collection – updates to inventories (DSL & NPRI) – Risk assessment – screening level risk assessments – Risk management measures for industrial & consumer applications of substances considered CEPA-toxic 19
Risk Assessment / Management Process Assessment Management Draft Environmental Gazette Gazette Gazette Gazette Gazette Gazette Assessment Notice Notice Notice Notice Notice Notice EC Final s.64 (a) & (b) Proposed Ministers Proposed Final Proposed RM conclusion Final Order Order RM Instrument conclusion Instrument “Toxic or “Addition to “Addition to s. 91(1 ) Draft s. 91(1) non-toxic” “Toxic or List of Toxic List of Toxic Human Health non-toxic” Substances” Substances” s.77(1) (Schedule 1 (Schedule 1 HC Assessment s.77(6) of CEPA) of CEPA) s.64 (c) s.77(9) & 90(1) s.77(9) & 90(1) 60-day 60-day 60-day public comment public comment public comment period period period Maximum 24 months Maximum 18 months Self-imposed Timelines for Challenge Public consultation on proposed conclusion Source: Environment Canada, An Overview of the Chemicals Management Plan and Challenge , 20 Ministerial decision-making presentation to the CMP Stakeholder Advisory Governor-in-council decision-making Council, January 25, 2008. Ministerial or Governor-in-council decision-making
CEPA: Existing Chemicals – Categorization / CMP Gaps • Gap # 1- A chemical considered P & B does not meet categorization environment criteria & is not considered for further screening or reduction action – Must also be inherently toxic – Over 250 DSL substances P & B but not iTe – Therefore, not assessed or managed under CMP 21
CEPA: Existing Chemicals – Categorization / CMP Gaps • Gap # 2 – Many substances not meet very high CMP PBT criteria (e.g. P if ½ life in water =/> 26 weeks); if CMP applied criteria from other jurisdictions, more chemicals would be PBT under CEPA – GLWQA (Can-US) (P if ½ life water 8 weeks) – REACH (Europe) (5.7 weeks) – PBT (USEPA) (8.5 weeks) – Stockholm POPs Convention (8.5 weeks) 22
CEPA: Existing Chemicals – Categorization / CMP Gaps • Gap # 3 – Categorization health effects assessments considered carcinogenicity, genotoxicity, reproductive toxicity, developmental toxicity, and mutagenicity, but did not consider endocrine toxicity 23
CEPA: Existing Chemicals – Categorization / CMP Gaps • Gap # 4 – DSL list over 30 years old and subject to inaccuracies – 2001 Health Canada study found quantities of 7 of 110 chemicals surveyed were order of magnitude greater than 1986 base year – NPRI data can update release information for chemicals on both lists but NPRI only reports on roughly 350 chemicals from large facilities – Can lead to wrong conclusions about exposure and incorrect management action 24
CEPA: Existing Chemicals – Categorization / CMP Gaps • Gap # 5 – Uncertainty regarding categorization results due to data gaps – Categorization relied on existing data – Missing information & data gaps filled by use of models (QSAR) & analogues (information from a similar but not identical chemical) – Categorization made limited use of surveys to gather data from industry; did not consider breakdown products of parent chemicals or toxicity for parent chemicals’ full life cycle 25
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